BUSINESS

US FDA Grants Orphan Exclusivity for ALS Drug Radicava ORS

April 10, 2024
Mitsubishi Tanabe Pharma said that the US FDA has awarded seven years of orphan drug exclusivity for its oral suspension version of the ALS therapy Radicava (edaravone), Radicava ORS. The designation was granted on March 28. Radicava ORS is a…

To read the full story

Related Article

BUSINESS

Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…

By Shinya Sato

Japan is opening a new chapter in sleep medicine. The recent decision to allow medical institutions to advertise “sleep disorders”…

By Philip Carrigan

Let’s face it: in today’s world, changing jobs is a normal part of a successful career. But if it’s so normal, why does it feel so hard? For many people, the idea of leaving their current role brings a heavy…

Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…

By Ken Yoshino

The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…

The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…

Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…

Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…